SAN DIEGO — ClearNote Health has announced the start of patient enrollment for a major clinical study evaluating its Avantect® Pancreatic Cancer Test, a blood-based diagnostic aimed at detecting pancreatic cancer at its earliest stages. The study, known as SAFE-D (Surveillance of pAncreatic health aFter diabEtes Diagnosis), is sponsored by the University Hospital Southampton NHS Foundation Trust and will enroll up to 15,000 patients across the UK—making it the largest study of its kind.
The multicenter, prospective, randomized controlled study is focused on individuals recently diagnosed with type 2 diabetes, a group shown to have a six- to eight-fold higher risk of developing pancreatic cancer compared to the general population. In some cases, the onset of diabetes may be driven by underlying pancreatic tumors affecting insulin production, highlighting the need for targeted early detection tools.
Led by consultant pancreatic surgeon Mr. Zaed Hamady, the study will be conducted by the Southampton Clinical Trials Unit (CTU) at the University of Southampton. Researchers aim to gather extensive prospective validation data on the Avantect test, while also exploring the relationship between new-onset diabetes and pancreatic cancer risk.
“This patient group provides a valuable opportunity to better understand how these diseases are linked,” said Hamady. “We believe this study will help validate ClearNote Health’s innovative approach to early detection using a blood-based test.”
The Avantect test analyzes the epigenomic biomarker 5-hydroxymethylcytosine (5hmC) in cell-free DNA along with other genomic signals to identify early-stage pancreatic cancer. Designed for high-risk populations—including individuals over 50 with recent type 2 diabetes diagnoses, those with a family history of pancreatic cancer, or with genetic predispositions—the test seeks to uncover cancer in stages I and II, when treatment outcomes are significantly more favorable.
Samuel Levy, PhD, Chief Scientific Officer at ClearNote Health, said the company is proud to participate in what could be a game-changing effort for early pancreatic cancer diagnosis. “We intend to show that the Avantect test can shift the paradigm of detection to earlier stages and offer real hope for patients facing one of the deadliest forms of cancer,” Levy said.
The study also prioritizes accessibility and equity. According to Dr. Victoria Goss of the Southampton Clinical Trials Unit, the SAFE-D initiative will be conducted through local research hubs and community hospitals to ensure broader participation across different demographics.
Dr. Mikayala King, Sponsorship Manager at University Hospital Southampton, described the study as a milestone in cancer research. “This collaboration with ClearNote builds on our strong track record in cancer diagnostics, and we are excited about its potential to improve patient outcomes on a national scale,” she said.
With patient enrollment now underway, the SAFE-D study could significantly advance the role of liquid biopsy-based diagnostics in catching pancreatic cancer before it progresses—offering a new lifeline for patients who often receive diagnoses too late for effective intervention.
